NDC 54111-155 Spf Ventures Brush On Block

Zinc Oxide 21.4%

NDC Product Code 54111-155

NDC 54111-155-50

Package Description: 162 mL in 1 TUBE

NDC Product Information

Spf Ventures Brush On Block with NDC 54111-155 is a a human over the counter drug product labeled by Bentley Laboratories, Llc. The generic name of Spf Ventures Brush On Block is zinc oxide 21.4%. The product's dosage form is cream and is administered via topical form.

Labeler Name: Bentley Laboratories, Llc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Spf Ventures Brush On Block Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ZINC OXIDE 21.4 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • SAFFLOWER OIL (UNII: 65UEH262IS)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)
  • MANDARIN OIL (UNII: NJO720F72R)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GALACTOARABINAN (UNII: SL4SX1O487)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL LAURATE (UNII: Y98611C087)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
  • METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)
  • POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
  • JOJOBA OIL (UNII: 724GKU717M)
  • PHYTATE SODIUM (UNII: 88496G1ERL)
  • STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bentley Laboratories, Llc
Labeler Code: 54111
FDA Application Number: part347 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-28-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Spf Ventures Brush On Block Product Label Images

Spf Ventures Brush On Block Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Drug Factsactive Ingredients

Zinc Oxide 21.4%

Purpose

Sunscreen

Uses

• helps prevent sunburn• if used as directed with other sun  protection measures (see Directions),  decreases the risk of skin cancer and early  skin aging caused by the sun

Warnings

For external use onlyDo not use on damaged or broken skinWhen using this product keep out of eyes.Rinse with water to removeStop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally (generously) 15 minutes before sun exposurereapply:   • after 80 minutes of swimming or sweating    • immediately after towel drying    • at least every 2 hours • Children under 6 months: Ask a doctor

Inactive Ingredients

Caprylic/capric triglyceride, carthamustinctorius (safflower) seed oil, cetearylalcohol, cetearyl glucoside, citric acid,citrus aurantium dulcis (orange) peel oil,citrus reticulata (tangerine) peel oil, cocosnucifera (coconut) oil, ethylhexylglycerin,galactoarabinan, glycerin, glyceryllaurate, glyceryl stearate, hydrogenatedpalm glycerides, isostearic acid, lecithin,methyl dihydroabietate, phenoxyethanol,polyglyceryl-10 oleate, polyglyceryl-3polyricinoleate, polyhydroxystearic acid,polysorbate 20, potassium cetyl phosphate,simmondsia chinensis (jojoba) seed oil,sodium phytate, stearyl/octyldodecyl citratecrosspolymer, water/aqua/eau, xanthan gum

Otc - Questions

Questions or Comments?Call toll free 1-800-916-7690

Brushonblock Labeling

BRUSHONBLOCK​®NON-NANO ZINC OXIDEMINERALSUNSCREENLOTIONUVA/UVB PROTECTIONWATER RESISTANT 80 MIN.BROAD SPECTRUM SPF 30DIST. BY BRUSH ON BLOCKPORTLAND, OR 97223, USAMADE IN USABRUSHONBLOCK.COMRES

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